Effect of Periorbital Massage on Dry Eye Disease

Dry Eye Clinical Trial

Official title:

Effect of Periorbital Massage on Dry Eye Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06390644
• Other study ID #: MSRSW/Batch-Fall22/701
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.

Description:

Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Symptoms of dry eye (such as burning, dryness or foreign body sensation)

• Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)

• Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol

Exclusion Criteria:

• Active ocular infection

• Ocular surgery within past 3 months

• Use of contact lenses

• Use of systemic medications that can affect tear production or tear quality

• Pregnancy or lactation

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Diagnostic Test:
• Periorbital Massage Therapy
Participants in this arm will receive periorbital massage therapy administered by a trained practitioner. The massage technique will involve gentle circular motions around the eye sockets and brow bone area, aiming to improve eyelid and tear gland function.

Other:
• Control Group (Standard Care)
Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy."

Locations

Country	Name	City	State
Pakistan	Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer Strips	Schirmer's test is used to determine whether the eye produces enough tears to keep it moist. The test is performed by placing filter paper inside the lower lid of the eye. After 5 minutes, the paper is removed and tested for its moisture content.	12 Months
Secondary	OSDI Questionnaire	The Ocular Surface Disease Index (OSDI) is a questionnaire that has been validated to discriminate between normal, mild to moderate, and severe dry eye disease as defined by the physician's assessment and a composite disease severity score	12 Months